Abstract: On March 10, 2023, the US Food and Drug Administration (FDA) issued the proposed rule “Requirements for Tobacco Product Manufacturing Practice” (TPMP) 21 CFR Part 1120 for manufacturers of finished and bulk tobacco products. The proposed requirements provide a framework for tobacco product design and development, risk assessment, manufacturing traceability, and Corrective and Preventive Action (CAPA) documented processes to help protect the public health by minimizing or preventing contamination, incorporating traceability down to batch ingredients, reducing additional risks to users and non-users, and ensuring product conformity and consistency. FDA acknowledges in the proposed rule, industry-leading tobacco product manufacturers are practicing elements of quality management systems (QMS) to support their manufacturing processes and traceability observed during Agency inspections. As the proposed TPMP rule undergoes the rulemaking process, it provides ample time for tobacco product manufacturers to conduct a robust assessment of their current QMS in place and a gap analysis to identify potential deficiencies needing remedy to ensure compliance with future TPMPs. Presented below are the proposed TPMP requirements highlighting the differences between existing GMPs, identifying the keys to successfully conducting a gap analysis between existing manufacturing processes and the proposed TPMP and best practices for implementing changes to manufacturing processes to comply with the TPMP rule.

Lillian Ortega, Lise Fraissinet, Chris Woodruff, Randy Freund, Kevin Burd

Affiliations: Chemular, Inc, Hudson, MI, USA